FDA.reportPublic FDA data

ADVIA Centaur® Systems HBc IgM QC

Primary DI
00630414470504
Brand
ADVIA Centaur® Systems HBc IgM QC
Company
Siemens Healthcare Diagnostics Inc.
Model
10308979
Catalog number
504945
Device description
HBc IgM (aHBcM) Quality Control Material Kit
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LOMTest, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
SEIQualitative and Quantitative Hepatitis B Virus Antibody assays

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOMTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)Microbiology2
SEIQualitative And Quantitative Hepatitis B Virus Antibody AssaysMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P030040000
P030040002
P030040004
P030040005
P030040006
P030040008
P030040009

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030040000ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI
P030040002ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI
P030040004ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI
P030040005ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI
P030040006ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI
P030040008ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI
P030040009ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALSSiemens Healthcare Diagnostics2004-08-06SEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414470504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414470504006304144705046304144705040630414470504

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the Hepatitis B virus core antigen in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store Upright, Protect from Light, Do not freeze, Resuspend.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590806323Access anti-HBc IgM Beckman Coulter, Inc.SEI2026-05-04
15099590806330Access anti-HBc IgM CalibratorBeckman Coulter, Inc.SEI2026-05-04
15099590806347Access anti-HBc IgM QCBeckman Coulter, Inc.SEI2026-05-04
15099590806293Hepatitis B Virus core Total AntibodyBeckman Coulter, Inc.SEI2026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORBeckman Coulter, Inc.SEI2026-03-30
15099590806316ACCESS anti-HBc Total QCBeckman Coulter, Inc.SEI2026-03-30
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